Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
- Conditions
- Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2
- Interventions
- Behavioral: Prochaska and DiClemente transtheorical model
- Registration Number
- NCT05969015
- Lead Sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Brief Summary
Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
- To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
- Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
- T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);
- Pregnant women;
- People living with HIV/AIDS;
- T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
- T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
- T2DM patients with severe eye and retine disease;
- Patients participating in another study simultaneously;
- Patients living with others in the same place.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Behavior-changing/Self-Management Prochaska and DiClemente transtheorical model This arm is composed by group-based interventions aiming to modify the self-management of the patients through the Prochaska and DiClemente transtheorical model. It is composed by weekly meetings, lasting up to 1 hour and a half, targeting eight patients per group. After the 12nd month of intervention, the meetings will be held each fifteen days untill the trial ending (18 months). The meetings will deal with lifestyle matters, such as nutrition, weight management, and physical activity, as well as medication adherence, blood glucose testing, and others. Whenever a care provider will be assigned to a group, he/she will go over untill the final of the trial, unless unexpected motivations appear. Patients achieving maintenance will receive green flag from the group-based interventions to avoid contamination. It is up to the care provider to perceive the readiness of the patient to another stage.
- Primary Outcome Measures
Name Time Method Glycemic control at 3-monthly intervals during 18 month Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)
- Secondary Outcome Measures
Name Time Method Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs at 6-monthly intervals during 18 month Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients
All-cause number of health care settings visits at 6-monthly intervals during 18 month All-cause number of health care settings visits measured by counts
Blood Pressure control at 6-monthly intervals during 18 month Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)
Body mass index at 6-monthly intervals during 18 month Anthropometric variables - kg per square meter
Abdominal circumference at 6-monthly intervals during 18 month Anthropometric variables - measured in centimeters (cm)
Diabetes Attitude Questionnaire (ATT-19) at 6-monthly intervals during 18 month ATT-19 is an instrument that seeks to measure psychological adjustment for diabetes mellitus, developed in response to the need for evaluation of the psychological and emotional aspects of the disease. It contains nineteen items that include six factors: a) DM-associated stress, b) treatment receptivity, c) trust in the treatment, d) personal efficiency, e) health perception, and f) social acceptance, with the answers measured using a five-point Likert scale (completely disagree - score 1; up to completely agree - score 5). The total value of the score can vary from 19 to 95 points. A score higher than 70 indicates a positive attitude toward the disease. In this instrument, attitude is related to the decision of the individual to adopt or not the self-care measures for diabetes control.
Attributable number of health care settings visits to type 2 diabetes mellitus at 6-monthly intervals during 18 month Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts
Weight at 6-monthly intervals during 18 month Anthropometric variables measured in kg
Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form at 6-monthly intervals during 18 month There are three levels of physical activity suggested for classifying populations; these are the new proposed levels, which take account of the concept of total physical activity of all domains. The proposed levels are: inactive; minimally active and HEPA activeí health-enhancing physical activity; a highly active category
Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A) at 6-monthly intervals during 18 month Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
High density lipoprotein levels - HDL-C at 3-monthly intervals during 18 month Serum HDL-C levels in mg/dL
Total cholesterol levels - TC at 3-monthly intervals during 18 month Serum TC levels in mg/dL
Height at 6-monthly intervals during 18 month Anthropometric variables -measured in meters
Depression scores by Hamilton Depression Rating Scale - HDR-S at 6-monthly intervals during 18 month A score of 0-7 is generally accepted to be within the normal range (or in clinical emission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Creatinine levels at 3-monthly intervals during 18 month Serum creatinine levels in mg/dL
Low density lipoprotein levels - LDL-C at 3-monthly intervals during 18 month Serum LDL-C levels in mg/dL
Total triglycerides levels - TG at 3-monthly intervals during 18 month Serum TG levels in mg/dL
MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil at 6-monthly intervals during 18 month Qualitative assessment of food intake for the previous day.
Diabetes Mellitus knowledge (DKN-A) at 6-monthly intervals during 18 month The measuring scale used is from 0 to 15. A score of one (1) is attributed to the correct answer and of zero (0) for the incorrect answer. A score higher than eight (8) indicates knowledge about diabetes mellitus
Trial Locations
- Locations (1)
Universidade do Extremo Sul Catarinense
🇧🇷Criciúma, Santa Catarina, Brazil